Study of Dermal Interstitial Fluid Collection With a Vacuum-Assisted Microneedle Device

ConditionHealthy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSharon Pitteri

About this trial

This study evaluates the collection of dermal interstitial fluid using a vacuum-assisted microneedle device in healthy adult volunteers.

The study will assess the device-based collection procedure and characterize the collected dermal interstitial fluid.

Healthy adult volunteers will undergo dermal interstitial fluid collection using a vacuum-assisted microneedle device at the Stanford study site. Participants will complete the study procedures described in the protocol, which may include device application, vacuum-assisted microneedle sampling, collection and analysis of dermal interstitial fluid, assessment of procedure-related effects, and follow-up as specified by the study protocol.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older.

Willing to undergo microneedle array patch (MAP) application.

Disqualifiers

History of skin conditions that predispose the participant to adverse reactions to skin puncture. Examples include eczema, psoriasis, and keloids.

Active infection, open wound, rash, or skin breakdown on the arm being used for MAP device application.

Known allergy to acrylate or device materials.

Trial design

Design model

Single group

Treatments tested in this trial

Vacuum-Assisted Microneedle Device
Device
The device comprises an adhesive alignment plate, an applicator containing a microneedle array patch, and a porous dome connected to a pre-evacuated collection tube. The patch is applied to the skin and immediately removed with the applicator. Vacuum then draws dermal interstitial fluid into the dome. Collection typically lasts 5 minutes, with a maximum of 30 minutes per attempt and an expected yield of approximately 15 microliters. Up to two additional collections at different skin sites are permitted with participant permission if the yield is insufficient. Configurations may use different-size collection tubes; flat domes or domes with different curvature radii; and aligned-perforation or triply periodic minimal surface lattice geometries. Each participant receives one configuration.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Vacuum-Assisted Microneedle Interstitial Fluid CollectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Volume of Dermal Interstitial Fluid Collected

Volume of dermal interstitial fluid obtained using the vacuum-assisted microneedle device, measured in microliters. Collection performance will be evaluated for the device configuration used during each participant's study visit.

Time frame

Baseline

Secondary outcomes

Participant-Reported Pain Associated With Device Use,Reported Ability to Operate the Device With Minimal Assistance and safety

Each participant will receive a survey asking them to rate the pain associated with ISF collection. Some participants will be asked to operate the device with minimal assistance. Study personnel will observe task completion and note difficulties. Safety events will be identified through the investigator's observation during the procedure and participant reports of delayed events.

Time frame

Baseline and up to 30 days.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sharon Pitteri

Lead sponsor

Stanford University

Sponsor institution

Stanford University

Collaborator

Source ClinicalTrials.gov

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